Identification of the sentinel node in breast cancer with fluorescence lymphography using indocyanine green dye (ICG): pilot study.

Conditions: BREAST CANCER
MedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-021815-18-IT

Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 255

Inclusion Criteria

Age = 18 years; - Cytologically or histologically diagnosis of breast cancer; - Primary tumor with a diameter = 3 cm; - Negative clinical evaluation of axilla; - Signed Informed Consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 255
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Hypersensitivity / known allergy to ICG, sodium iodide or iodine; - Hyperthyroidism; - Thyroid carcinoma; - Pregnancy and / or lactation; - Taking drugs that affect liver function; - Renal failure; - Taking medications that can alter the absorption of indocyanine-green; - Psychiatric disorders or any disease that compromises the ability to provide informed consent for participation in this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: validation of new method, the fluorescence lymphography by comparison with the gold standard method, the radio colloid;Secondary Objective: ;Primary end point(s): - Validation of the new method, the fluorescence lymphography, by direct comparison with the gold standard method, the radio colloid. It will be calculated the Predictive Positive Value as the LS identified percentage both through ICG and gold standard on the LS value identified through ICG . We will calculated the new diagnostic approach Sensitivity ICG as the percentage of LS identified both through ICG and gold standard on the LS value identified through gold standard .;Timepoint(s) of evaluation of this end point: after the histological evaluation of the linfonodes

Secondary Outcome Measures